Posted by Michael Wonder on 28 Nov 2018
European Commission approves Alunbrig (brigatinib) for ALK positive, non-small cell lung cancer in patients previously treated with crizotinib, advancing treatment paradigm in Europe
28 November 2018 - Alunbrig demonstrated unprecedented median progression-free survival of 16.7 months and overall survival of 34.1 months in the post-crizotinib setting.
Takeda today announced that the European Commission granted marketing authorisation for Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. The decision follows a positive opinion from the CHMP on 20 September 2018.
The European Commission’s approval is based on data from the global Phase 2 ALTA trial, in which patients were randomised to receive one of two dosing regimens of Alunbrig: 90 mg once daily (n=112) or the recommended dosing regimen of 180 mg once daily with seven-day lead-in at 90 mg once daily (n=110).
